Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-11

Study Completion Date

2009-06-15

Brief Summary

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The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.

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Detailed Description

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Obstructive sleep apnea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed or auto adjusted positive pressure to the upper airway via a tube and mask. The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilizes an improved algorithm which should maintain or enhance the effectiveness of the treatment.

Conditions

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Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Nexus Flow Generator

Participants were randomised to Nexus Flow Generator group for one night.

Group Type EXPERIMENTAL

Nexus Flow Generator

Intervention Type DEVICE

The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilises an improved algorithm which should maintain or enhance the effectiveness of the treatment.

VPAP Flow Generator 25

Participants were randomised to VPAP Flow Generator 25 group for one night.

Group Type ACTIVE_COMPARATOR

VPAP Flow Generator 25

Intervention Type DEVICE

Exiting VPAP Auto 25 Flow Generator with A10 Algorithm

Interventions

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Nexus Flow Generator

The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilises an improved algorithm which should maintain or enhance the effectiveness of the treatment.

Intervention Type DEVICE

VPAP Flow Generator 25

Exiting VPAP Auto 25 Flow Generator with A10 Algorithm

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18-80 years
* Patients who are on CPAP therapy in AUTOSET mode for no less than 6 months
* Patients who are using ResMed masks

Exclusion Criteria

* Patients who are unable to provide written informed consent
* Patients who are unable to comprehend written and spoken English
* Patients who are using Bilevel PAP
* Patients who are pregnant
* Patients who are suffering any of the following:

* Acute respiratory infection
* Acute sinusitis, otitis media or perforated eardrum
* Pneumothorax or pneumomediastinum
* Recent history of severe epistaxis requiring medical attention

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No